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Recall Observatory FDA recall evidence

Drug product

Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25

D-1241-2019

April 23, 2019

Class III

Product summary

Firm
Akorn Inc
Event
Event 82657
Status
Terminated
Classification
Class III
Quantity
5,380 cartons (25 ampules per carton)
Official record key
drug-enforcement:D-1241-2019

Official wording

Reason: Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.

Code information: Lot #: 011198, Exp 01/22

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of Specification